The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biostrep A, Biosign Strep A, Statusfirst Strep A.
| Device ID | K082661 |
| 510k Number | K082661 |
| Device Name: | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Kyung-ah Kim |
| Correspondent | Kyung-ah Kim PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-12 |
| Decision Date | 2008-10-06 |